Events

Recall of Device Recall Stryker

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Medical Div. of Stryker Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    35536
  • Event Risk Class
    Class 2
  • Event Number
    Z-1155-06
  • Event Initiated Date
    2006-05-15
  • Event Date Posted
    2006-06-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46349
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Mobile Surgery Platform - Product Code FSE
  • Reason
    An incorrect pin may have been used during assembly and therefore the device may give way during use.
  • Action
    Consignees were called on 5/15/06 and instructed to discontinue use of these devices until the firm's technician has visited the facility and replaced the pin.

Device

Device Recall Stryker
  • Model / Serial
    Serial numbers 0412060619, 0501073240, 0501073241, 0501073327, 0501073328, 0501073329, 0501073330, 0408062292, 0408062293, 0502069215, 0504072232, 0409062008, 0409062003, 0409062004, 0409062005, 0409062006, 0410065050, 0502069214, 0410058767, 0409062001, 0409062274, 0512070516, 0602079782, 0602079817, 0602079818, 0602079819, 0408062389, 0408062390, 0408062391, 0409062007, 0411060535, 0506071242, 0410065046, 0501073064, 0501073065, 0501073066, 0501073084, 0501073085, 0501073086, 0501073087, 0501073188, 0501073189, 0501073190, 0602079542, 0506071118, 0510071070, 0510071071, 0510071072, 0605087579, 0504072089, 0602079541, 0505069588, 0502069314, 0502069315, 0510071241, 0511071674, 0511071675, 0511071676, 0511071677, 0511071678, 0511071679, 0511071680, 0504072088, 0512070514, 0512070515, 0412060744, 0412060745, 0412060746, 0412060855, 0412060856, 0412060857, 0501073001, 0501073002, 0501073003, 0502069148, 0601084043, 0507070537, 0510071069, 0502069034, 0502069035, 0502069036, 0502069150, 0502069151, 0502069152, 0502069153, 0510071243, 0410058765, 0507070691, 0507070692, 0507070693, 0507070694, 0507070695, 0507070696, 0507070697, 0507070698, 0507070699, 0507070700, 0603084573, 0409062002, 0410058766, 0502069149, 0503068501, 0503068502, 0503068503, 0506071116, 0506071117, 0506071241, 0603084574, 0410065049, 0501073373, 0501073374, 0501073375, 0501073376, 0502069032, 0502069033, 0502069313, 0603084672, 0411060618, 0411060619, 0411060620, 0411060621, 0411060802, 0411060803, 0411060804, 0412060504, 0412060505, 0412060506, 0412060616, 0412060617, 0412060618, 0505069589, 0505069590, 0505069591, 0505069592, 0410065047, 0509069501, 0509069502, 0505069749, 0505069750, 0502069216,  0410065045, 0410065048, 0411060801, 0408062151, 0409062273, 0409062275, 0502069312, 0503068633, 0503068634, 0503068635, 0503068636, 0511071540, 0511071541, 0511071542, 0511071543 and 0503068637.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide (including USA, Australia, Canada, England, Germany, Italy, Romania and Singapore).
  • Product Description
    Stryker Trio Mobile Surgery Platform; Model 1033.
  • Manufacturer
    Stryker Medical Div. of Stryker Corporation

Manufacturer

Stryker Medical Div. of Stryker Corporation
  • Manufacturer Address
    Stryker Medical Div. of Stryker Corporation, 3800 E. Centre Ave., Portage MI 49002
  • Source
    USFDA